Manager / Sr Manager Regulatory Affairs– US Markets
3 weeks ago
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.As part of our further expansion and growth plans, we are looking to hireManager / Sr Manager Regulatory Affairs– US MarketsinRegulatory Affairsdepartment.This position is based at ourR&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.Key Responsibilities:Regulatory Submissions: Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) Ensure compliance with current USFDA regulations and guidance documents FDA Interactions: Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) Participate in and support FDA meetings as the regulatory lead Handle Controlled Correspondence with the FDA for product development and regulatory strategy Product Expertise: Provide regulatory support forcomplex formulations , includinginjectables and liquid dosage forms Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle Leadership & Communication: Lead a team of regulatory professionals, providing guidance, training, and performance management Communicate effectively with internal stakeholders and external regulatory bodiesQualifications & Experience:Master’s degree in Pharmacy 13–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes Strong understanding of injectables, liquid dosage forms, and complex generics Excellent written and verbal communication skills Demonstrated leadership and team management capabilities
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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navi mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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navi mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Manager-Biologics Regulatory Affairs
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Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per yearYou will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...
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Regulatory Affairs Manager
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Mumbai, India Chemill Pharma Ltd. Full timePurpose of the Role: Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading...
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Regulatory Affairs Manager
1 week ago
mumbai, India Chemill Pharma Ltd. Full timePurpose of the Role: Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading...
